FDA, CDC Says Don't Use Any Product From New England Compounding Center

The Framingham-based company is linked to an outbreak of fungal meningitis in 23 states that has left 5 people dead.

The Centers for Disease and Control and Prevention and Food and Drug Administration announced today they are advising medical professionals not to use any products manufactured by the New England Compounding Center in Framingham, due to an outbreak of fungal meningitis tied to some medications made by the company.

An inspection of the pharmacy's Framingham company earlier this week found fungus in a sealed vial of the steroid, according to the U.S. Food and Drug Administration. Agency officials warned against using any of the firm's drugs.

"Out of an abundance of caution, we advise all health care practitioners not to use any product" from the company, said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.

"Immediately discontinue use and isolate" the products from other medicines, Bernstein, said in a conference call with reporters.

New England Compounding Center is the maker of a steroid containing a fungal form of meningitis, that has been linked to five deaths across the country and dozens of people infected.

Last week, the company issued a recall of three lots of the steroid.

Dr. Benjamin Park, medical epidemiologist with the Centers for Disease Control and Prevention, told reporters that 23 states may have received shipments of the tainted product. Massachusetts is not one of the states. A total of 75 facilities across the nation may have received product from one of three recalled lots.

However, because the New England Compounding Center is licensed in all 50 states, there is a possibility contaminated products may be in other areas, Bernstein said.

“The Massachusetts Department of Public Health is collaborating with the CDC, FDA, and other state public health officials to identify the cause of an outbreak of more than 25 suspected cases of aspergillus (fungal) meningitis under investigation in Florida, Maryland, North Carolina, Tennessee and Virginia. The cause for this cluster of cases is not yet known. There are four products common to all of these cases. One medication, Methylprednisolone Acetate, a steroid, was prepared at the New England Compounding Center, Inc (NECC), a pharmacy in Framingham, Massachusetts. It has been recalled and quarantined as a precaution. NECC is voluntarily recalling all similar medications. In addition, at the request of DPH, NECC has agreed to voluntarily surrender their license to operate until this investigation is complete. The form of fungal meningitis in these patients is not transmitted from person to person. There are no known cases in the Commonwealth.”

The Framingham company released this statement Wednesday:

“New England Compounding Center (NECC) is working closely with the Massachusetts Department of Public Health, the Massachusetts Board of Pharmacy and other regulators to identify the source of infection in patients who received injections of methylprednisolone acetate. Upon notification of incidents of infection, NECC immediately initiated a voluntary recall of this product on Sept. 26. As part of this process, we have voluntarily suspended operations while we assist authorities in their investigation.”

Operations at the Framingham-based company have been suspended.


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